Actively Recruiting

Age: 18Years +
All Genders
NCT07561424

Comparisons Of Biochemical And Clinical Outcomes Of Hemodialysis Patients Treated With Middle Cut-Off Dialyzers Versus High-Flux Hemodialysis Or Hemodiafiltration

Led by Arbor Research Collaborative for Health · Updated on 2026-05-01

1000

Participants Needed

1

Research Sites

30 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The CONCORDIA study is a retrospective, observational study evaluating clinical and biochemical outcomes among patients receiving maintenance hemodialysis with medium cut-off (MCO) dialyzers (Theranova) compared with high-flux hemodialysis (HF-HD) and hemodiafiltration (HDF). Using real-world data from non-DOPPS Theranova sites and the DOPPS cohort as an external control, the study aims to assess whether MCO dialyzers are associated with improved outcomes versus HF-HD and non-inferior outcomes compared with HDF. The primary outcome is all-cause mortality, with secondary outcomes including cardiovascular events, hospitalizations, infections, and laboratory measures related to anemia, mineral metabolism, and inflammation.

CONDITIONS

Official Title

Comparisons Of Biochemical And Clinical Outcomes Of Hemodialysis Patients Treated With Middle Cut-Off Dialyzers Versus High-Flux Hemodialysis Or Hemodiafiltration

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years of age or older
  • Treated at an in-centre dialysis clinic
  • Receiving chronic, maintenance HD
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

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Trial Site Locations

Total: 1 location

1

AURA

Paris, France

Actively Recruiting

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Research Team

R

Roberto Pecoits-filho, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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